The Effects of Coffee Main Constituents (Caffeine and Chlorogenic Acid) Supplementation on Inflammatory, Metabolic Factors, Hepatic Steatosis and Fibrosis in None- Alcoholic Fatty Liver Patients With Type 2 Diabetes

The purpose of this study is to investigate the effects of coffee main constituents (caffeine and chlorogenic acid) supplements on inflammatory, metabolic factors, hepatic steatosis and fibrosis in none- alcoholic fatty liver patients with type 2 diabetes. Two hundred patients with fatty liver and type 2 diabetes will be randomly assigned to one of four groups: group 1, caffeine (200 mg/d) plus chlorogenic acid (200 mg/d); group 2, caffeine (200 mg/d) plus placebo; group 3, chlorogenic acid (200 mg/d) plus placebo; group 4, placebo plus placebo. Supplementation will be daily and will supervise for 6 months.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Nonalcoholic Fatty Liver
• Intervention / Treatment: Dietary supplement: caffeine and chlorogenic acid; Dietary supplement: caffeine; Dietary supplement: chlorogenic acid; Dietary supplement: placebo

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, 19435
    • NNFTRI clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient diagnosed with type 2 diabetes based on American Diabetes Association (ADA) definition or who only take oral antidiabetic drug.
• CAPscore >263

Exclusion Criteria:

• Criteria:

  • Taking any kind of antibiotics two weeks before recruitment;
  • History of alcohol consumption ;
  • pregnancy or lactation;
  • Professional athletes;
  • Other liver disease (viral/etc);
  • High dose synthetic estrogens, methotrexate , amiodarone, steroids, chloroquine, immunosuppressive drugs;
  • A history of Cardiovascular disease;
  • Renal disease, Celiac disease, Cirrhosis;
  • History of Upper Gastrointestinal surgery ;
  • A history of hypothyroidism or Cushing's syndrome;
  • History of drug dependence;
  • Body mass index (BMI) ≥35 kg/m2;
  • A restrictive diet or weight change ≥ 5 kg during the 3 months prior to study;
  • Any change in treatment with oral hypoglycemic; anti hypertensive and antilipid agents during the study;
  • Use of weight loss medications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: caffeine and chlorogeinc acid; caffeine (200 mg) 1 capsule / day for 6 months plus chlorogenic acid (200 mg) 1 capsule / day for 6 months	Dietary supplement: caffeine and chlorogenic acid; caffeine plus chlorogenic acid
Active Comparator: caffeine; caffeine (200 mg) 1 capsule / day for 6 months plus placebo (200) mg 1 capsule / day for 6 months	Dietary supplement: caffeine; caffeine plus placebo
Active Comparator: chlorogenic acid; chlorogenic acid (200 mg) 1 capsule / day for 6 months plus placebo (200 mg) 1 capsule / day for 6 months	Dietary supplement: chlorogenic acid; chlorogenic acid plus placebo
Placebo Comparator: placebo; placebo (200 mg) 1 capsule / day for 6 months plus placebo (200 mg) 1 capsule / day for 6 months	Dietary supplement: placebo; placebo plus placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hepatic steatosis	measured by CAP score using Fibroscan	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Glucose	6 months
Glycated hemoglobin (HBA1C)	6 months
alanine aminotransferase (ALT)	6 months
aspartate aminotransferase (ALS)	6 months
High sensitive C reactive protein ( hs- CRP)	6 months
gut microbiota	3 months

Collaborators and Investigators

• Sponsor: National Nutrition and Food Technology Institute

Publications and helpful links

General Publications

• Mansour A, Mohajeri-Tehrani MR, Karimi S, Sanginabadi M, Poustchi H, Enayati S, Asgarbeik S, Nasrollahzadeh J, Hekmatdoost A. Short term effects of coffee components consumption on gut microbiota in patients with non-alcoholic fatty liver and diabetes: A pilot randomized placebo-controlled, clinical trial. EXCLI J. 2020 Mar 2;19:241-250. doi: 10.17179/excli2019-2021. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: October 9, 2016
• First Submitted That Met QC Criteria: October 9, 2016
• First Posted (Estimate): October 11, 2016

Study Record Updates

• Last Update Posted (Actual): May 1, 2019
• Last Update Submitted That Met QC Criteria: April 28, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Liver Diseases; Diabetes Mellitus, Type 2; Fatty Liver; Non-alcoholic Fatty Liver Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Caffeine
• Other Study ID Numbers: 147